510(k) K181537
K181537 is an FDA 510(k) premarket notification submitted by Leica Microsystems (Schweiz) AG for the device "GLOW800". The FDA issued a decision of Substantially Equivalent on September 7, 2018. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Leica Microsystems (Schweiz) AG has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 7, 2018
- Date Received
- June 11, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Angiographic
- Device Class
- Class II
- Regulation Number
- 892.1600
- Review Panel
- RA
- Submission Type